Baylis Medical Company, Inc.
Baylis Medical Company, Inc. holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2025, with 3 FDA device recalls on record.
Top product codes for Baylis Medical Company, Inc.
FDA recalls by Baylis Medical Company, Inc.
- Z-2069-2020 — TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.
- Z-2070-2020 — NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
- Z-0879-2013 — BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Baylis Medical Company, Inc.
- K251325 — VersaCross Connect Transseptal Dilator
- K241720 — VersaCross Connect Transseptal Dilator
- K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
- K233647 — VersaCross Connect Transseptal Dilator
- K213898 — ProTrack Pigtail Wire
- K221351 — Mechanical Guidewire
- K213582 — Epicardial Access System
- K220414 — VersaCross Connect Transseptal Dilator
- K201288 — ExpanSure Large Access Transseptal Dilator
- K191546 — Epicardial Access System
- K183632 — Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
- K183649 — Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
- K183655 — VersaCross Transseptal Sheath
- K190688 — VersaCross Steerable Sheath, VersaCross Transseptal Dilator
- K182064 — ExpanSure Transseptal Dilation System
- K181864 — Polaris RF Ablation System
- K161949 — OsteoCool V-3 RF Ablation System
- K161878 — PORTAGE System
- K152057 — OsteoCool V-3 RF Ablation System
- K151009 — Nexus Suture
- K150709 — ProTrack RF Anchor Wire
- K142480 — OsteoCool V-2 RF Ablation System
- K132374 — BAYLIS MEDICAL RF PERFORATION PROBE V2.0
- K122278 — BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.